Lecanemab (sold under the brand name Leqembi) helps reduce amyloid plaques in the brain, which are hallmarks of Alzheimer’s disease. Prevention’s recent article, “All About Lecanemab, the New FDA-Approved Alzheimer’s Drug,” reports that the drug was approved in January under the FDA’s Accelerated Approval pathway. This process allows the organization to approve drugs for serious conditions with unmet medical needs based on clinical data demonstrating the drug’s effect on a surrogate endpoint. However, the FDA required a clinical trial to verify the benefit and efficacy of lecanemab.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
The Centers for Medicare and Medicaid Services said that it will include lecanemab in its coverage, which is great because, without coverage, the annual treatment cost could be more than $26,000.
Lecanemab (a.k.a. Leqembi) is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease, the FDA explains. The drug works by reducing amyloid plaques that form in the brain, a hallmark of Alzheimer’s disease. This helps slow the progression of the disease.
There have been several studies on lecanemab and its effectiveness. Results of a clinical trial conducted at 235 different medical sites across North America, Europe, and Asia, published in the New England Journal of Medicine, found that lecanemab reduced cognitive and functional decline in patients with Alzheimer’s disease by 27%. It also found that patients who took the medication had more amyloid plaques cleared after 18 months on the drug.
The trial included 1,795 adults between 50 and 90 years of age with mild cognitive impairment due to early Alzheimer’s disease or mild Alzheimer’s disease-related dementia, grouped participants into those assigned to get lecanemab via IV infusion every two weeks or a placebo.
Participants in both groups had a clinical dementia rating of around 3.2 when the trial began. At the end of the 18-month trial, the score rose 1.2 points in the group that received lecanemab. However, it went up nearly 1.7 points in the placebo group.
The FDA says that lecanemab “demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint” compared to a placebo.
Reference: Prevention (July 8, 2023) “All About Lecanemab, the New FDA-Approved Alzheimer’s Drug”
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